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THE NATIONAL ACADEMIES PRESS 500 Fifth Street, N.W. Washington, DC 20001
NOTICE: The project that is the subject of this report was approved by the Governing
Board of the National Research Council, whose members are drawn from the councils of
the National Academy of Sciences, the National Academy of Engineering, and the Institute
of Medicine. The members of the committee responsible for the report were chosen for their
special competences and with regard for appropriate balance.
This study was supported by Contract No. N01-OD-4-2139, TO # 201 of the National Insti-
tutes of Health, Contract No. 63229 of the Robert Wood Johnson Foundation, The Greenwall
Foundation, the ABIM Foundation, Contract No. S07-2 of the Josiah Macy Jr. Foundation,
Contract No. 1007182 of the Burroughs Wellcome Fund, and also the endowment fund of
the Institute of Medicine, all contracts between the National Academies. Any opinions, find-
ings, conclusions, or recommendations expressed in this publication are those of the authors
and do not necessarily reflect the view of the organizations or agencies that provided support
for the project.
Library of Congress Cataloging-in-Publication Data
Conflict of interest in medical research, education, and practice / Bernard Lo and Marilyn
J. Field, editors ; Committee on Conflict of Interest in Medical Research, Education, and
Practice, Board on Health Sciences Policy.
p. ; cm.
Includes bibliographical references and index.
ISBN 978-0-309-13188-9 (hardcover)
1. Business and medicine. 2. Conflict of interests. I. Lo, Bernard. II. Field, Marilyn J.
(Marilyn Jane) III. Institute of Medicine (U.S.). Committee on Conflict of Interest in Medical
Research, Education, and Practice. IV. National Academies Press (U.S.)
[DNLM: 1. Conflict of Interest. 2. Biomedical Researchâethics. 3. Education,
Medicalâethics. 4. Ethics, Clinical. W 50 C748 2009]
RA394.C665 2009
174.2âdc22
2009020634
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Copyright 2009 by the National Academy of Sciences. All rights reserved.
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Museen in Berlin.
Suggested citation: IOM (Institute of Medicine). 2009. Conflict of Interest in Medical Re-
search, Education, and Practice. Washington, DC: The National Academies Press.

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www.national-academies.org

COMMITTEE ON CONFLICT OF INTEREST IN MEDICAL
RESEARCH, EDUCATION, AND PRACTICE
BERNARD LO (Chair), Professor of Medicine and Director, Program in
Medical Ethics, University of California, San Francisco
WENDY BALDWIN, Director, Poverty, Gender and Youth Program,
Population Council
LISA BELLINI, Associate Dean for Graduate Medical Education and
Associate Professor of Medicine, University of Pennsylvania
LISA A. BERO, Professor, Department of Clinical Pharmacy and Institute
for Health Policy Studies, University of California, San Francisco
ERIC G. CAMPBELL, Associate Professor, Institute for Health Policy
and Department of Medicine, Massachusetts General Hospital and
Harvard Medical School
JAMES F. CHILDRESS, Hollingsworth Professor of Ethics, Department
of Religious Studies and Professor of Medical Education and
Director, Institute for Practical Ethics, University of Virginia
PETER B. CORR, General Partner, Celtic Therapeutics Management
Company, L.L.P.
TODD DORMAN, Associate Dean and Director, Continuing Medical
Education, and Professor of Anesthesiology, Johns Hopkins Medical
Center
DEBORAH GRADY, Professor of Medicine and Director, Womenâs
Health Clinical Research Center and Associate Dean for Translational
Research, University of California, San Francisco
TIMOTHY S. JOST, Robert L. Willett Family Professor of Law,
Washington and Lee University School of Law
ROBERT P. KELCH, Executive Vice President for Medical Affairs,
University of Michigan and Chief Executive Officer, University of
Michigan Health System
ROBERT M. KRUGHOFF, President, Consumer CHECKBOOK/Center
for the Study of Services
GEORGE LOEWENSTEIN, Herbert A. Simon Professor of Economics
and Psychology, Department of Social and Decision Sciences,
Carnegie Mellon University
JOEL PERLMUTTER, Elliot Stein Family Professor of Neurology and
Professor of Radiology and Physical Therapy, Washington University
School of Medicine in St. Louis
NEIL R. POWE, Professor of Medicine, Epidemiology, and Health
Policy and Management and Director, Welch Center for Prevention,
Epidemiology, and Clinical Research, Johns Hopkins School of
Medicine and Bloomberg School of Public Health

Acknowledgments
In preparing this report, the committee and project staff benefited
greatly from the assistance and expertise of many individuals and groups.
Important information and insights came from four public meetings that
the committee organized to collect information and perspectives from a
range of academic, professional, consumer, patient, and other organiza-
tions and individuals. A number of speakers at these meetings also shared
their knowledge at other times during the course of the study. Appendix A
includes the agendas of the public meetings and a list of organizations that
submitted written statements of views.
The committee appreciates the contributions of the authors of the
background papers that appear as Appendix C (Michael Davis at Illinois
Institute of Technology and Josephine Johnston at the Hastings Center)
and Appendix D (Jason Dana at University of Pennsylvania). Our project
officer at the National Institutes of Health, Walter Schaffer, was always
helpful in getting our questions answered. We also called on Daniel Wolfson
at the American Board of Internal Medicine Foundation for information.
In addition, Ariel Winter of the Medicare Payment Advisory Commission
helped by answering questions about the commissionâs work. Mary Nix
at the Agency for Healthcare Research and Quality provided data from
the National Guidelines Clearinghouse that we could not obtain online.
An undoubtedly incomplete list of others who assisted the committeeâs
work includes David Atkins, James Bernat, Carol Blum, David Blumenthal,
Deborah Briggs, Laura Brockway-Lunardi, Robert Campbell, Roger Chou,
Vivian Coates, Allan Coukel, Bette Crigger, Susan Ehringhaus, Brian Eigel,
vii

Reviewers
This report has been reviewed in draft form by individuals chosen
for their diverse perspectives and technical expertise, in accordance with
procedures approved by the National Research Councilâs Report Review
Committee. The purpose of this independent review is to provide candid
and critical comments that will assist the institution in making its published
reports as sound as possible and to ensure that the report meets institutional
standards for objectivity, evidence, and responsiveness to the study charge.
The review comments and draft manuscript remain confidential to protect
the integrity of the deliberative process. We wish to thank the following
individuals for their review of this report:
Claudia R. Adkison, Emory University School of Medicine
Robert Baron, University of California, San Francisco School of
Medicine
Paul Citron, Medtronic, Inc. (Retired)
F. Sessions Cole, Washington University School of Medicine
Peter Densen, University of Iowa Carver College of Medicine
Thomas J. Fogarty, Fogarty Engineering
Leo T. Furcht, University of Minnesota
Linda Golodner, National Consumers League
Henry T. Greely, Stanford University Law School
Allen S. Lichter, American Society of Clinical Oncology
Joseph Loscalzo, Brigham and Womenâs Hospital
Alan Nelson, American College of Physicians Foundation
ix

REVIEWERS
Philip A. Pizzo, Stanford University School of Medicine
Richard Schilsky, University of Chicago Medical Center
Larry J. Shapiro, Washington University in St. Louis School of
Medicine
Harold Sox, Annals of Internal Medicine and American College of
Physicians
Jeremy Sugarman, Johns Hopkins Medical Institutions
P. Roy Vagelos, Merck & Co., Inc. (Retired)
Although the reviewers listed above have provided many constructive
comments and suggestions, they were not asked to endorse the conclusions
or recommendations, nor did they see the final draft of the report before its
release. The review of this report was overseen by David Challoner, Univer-
sity of Florida, and Judith L. Swain, National University of Singapore and
University of California, San Diego. Appointed by the National Research
Council and the Institute of Medicine, these individuals were responsible
for making certain that an independent examination of this report was car-
ried out in accordance with the institutional procedures and that all review
comments were carefully considered. Responsibility for the final content of
this report rests entirely with the authoring committee and the institution.

Preface
Hardly a week goes by without a news story about conflicts of inter-
est in medicine. While this committee met, colleagues and friends sent me
many news reports and journal articles on the topic. These reportsâeven
if one expects that initial news reports may not always have the stories
quite straightâserved as continual reminders that conflicts of interest cre-
ate deep concerns about the integrity of medicine and medical research and
raise questions about the trustworthiness of physicians, researchers, and
medical institutions.
As I look back over our deliberations, several themes stand out. First,
as with all Institute of Medicine (IOM) reports, the committee was charged
with making recommendations that were based on evidence and convinc-
ing reasons. Although the committee members were aware of powerful
anecdotes and had personal beliefs about the issues, we repeatedly asked
whether the evidence supported our conclusions and recommendations. If
it did not, we developed a reasoned case on the basis of the committeeâs
experience and the judgment of the committee members about the argu-
ments for the use of different approaches presented in the literature or in
statements submitted to the committee. Second, it is a challenge to craft
policy recommendations that strike the right balance between addressing
egregious cases and creating burdens that stifle relationships that advance
the goals of professionalism and generate knowledge to benefit society. The
committee tried to consider the possibility that well-intentioned policies
may have unintended adverse consequences. Third, regulation alone may
have limited effectiveness in the absence of a culture of professionalism
xi

xii PREFACE
and other incentives that are aligned to promote professional behavior.
The committee considered how a variety of organizationsâincluding those
that accredit health care institutions and license health care professionals,
publish the findings of medical research, use practice guidelines, and pay for
medical careâcan buttress the conflict of interest policies implemented by
institutions that carry out medical research, provide education and patient
care, and develop practice guidelines.
This report cannot and did not attempt to resolve all issues related to
conflicts of interest in medicine. In view of our expansive charge, we tried
to address central questions rather than the many details of this complex
topic. For example, we focus on conflicts that involve financial interests
because they are at the heart of concerns and debates about conflicts of
interest. Furthermore, because relationships with pharmaceutical, medical
device, and biotechnology companies have created the greatest concern and
were central in the discussions that led the IOM to pursue this study, we
focused on those relationships. The committee expects that many of the
recommendations and analyses in our report will also apply more generally
to professional and institutional relationships with other commercial enti-
ties, such as insurers and vendors of nonmedical products.
The committee could not resolve some important issues like harmoniz-
ing the different requirements for the disclosure of financial relationships
because they would require much more time and additional expertise.
Instead, to standardize aspects of disclosure policies and procedures, the
committee recommended a focused consensus development process that
would involve multiple stakeholders on the issue.
Our committee was diverse, involving members with different profes-
sional backgrounds and areas of expertise. These different perspectives led
to spirited discussions and debates. Each of us listened to points of view
and information that we had not previously considered. We tried to listen
to and understand other viewpoints and be open to new perspectives, even
if in the end we did not agree on all issues. Appendix F describes the differ-
ent views on one issue, a proposal by some committee members for broader
requirements for public disclosure. In general, the committee hoped that by
explaining our reasoning on difficult issues our audiences would better ap-
preciate the multiple considerations that a sound conflict of interest policy
should address.
As chair, I want to personally thank the committee members for their
hard work and their willingness to engage on difficult topics. I am deeply
grateful to them for the time and effort that they took from their busy
schedules to devote to this project. This report is truly a collaborative ef-
fort and is much the better, I think, for the back-and-forth discussions. I
also want to personally thank our IOM staff for their tremendous efforts
in making this report possible. Robin Parsell skillfully handled meeting

PREFACE xiii
and other logistics, and Franklin Branch provided research assistance in
many areas. Marilyn Field was unstinting in her background research,
drafting and revising of the manuscript, and high standards for our work.
And I want to thank Lindsay Parham, my research assistant at the Univer-
sity of California at San Francisco, for her expert help with background
research.
Bernard Lo, M.D., Chair
Committee on Conflict of Interest in
Medical Research, Education, and Practice

Contents
SUMMARY 1
1 INTRODUCTION 23
Overview and Themes of the Report, 27
Historical and Policy Context, 33
Organization of Report, 43
2 PRINCIPLES FOR IDENTIFYING AND ASSESSING
CONFLICTS OF INTEREST 44
What Is a Conflict of Interest?, 45
What Are the Purposes of Conflict of Interest Policies?, 48
Why Not Examine the Motives of the Decision Maker or the
Validity of the Decision?, 50
Should Policies Also Require That Professionals Avoid the
âAppearance of Conflict of Interestâ?, 52
How Can Conflicts of Interest Be Assessed?, 52
How Can Conflict of Interest Policies Be Evaluated?, 56
Conclusion, 60
3 POLICIES ON CONFLICT OF INTEREST: OVERVIEW AND
EVIDENCE 62
Overview of Conflict of Interest Policies, 64
Disclosure: An Essential but Insufficient Element of Policy, 67
Prohibiting or Eliminating Conflicts of Interests, 79
xv

CONTENTS xvii
9 ROLE OF SUPPORTING ORGANIZATIONS 230
How Supporting Organizations Can Influence Medical
Institutions, 232
Recommendations, 235
References 240
Appendixes
A Study Activities 285
B U.S. Public Health Service Regulations: Objectivity in Research
(42 CFR 50) 295
C Conflict of Interest in Four Professions: A Comparative
Analysis 302
D How Psychological Research Can Inform Policies for Dealing
with Conflicts of Interest in Medicine 358
E The Pathway from Idea to Regulatory Approval: Examples for
Drug Development 375
F Model for Broader Disclosure 384
G Committee Biographies 392
INDEX 401

Boxes, Figures, and Tables
BOXES
3-1 Model of Steps Used to Identify and Respond to a Conflict of
Interest, 65
3-2 Risks and Potential Benefits to Consider in Assessing the Severity of
a Researcherâs Conflict of Interest, 83
4-1 Examples of Biased Reporting in Clinical Research, 107
5-1 AAMC Recommendations on Site Access by Sales
Representatives, 134
5-2 Example of a Solicitation of Industry Support (Educational Grants)
for a Large Accredited Continuing Medical Education Program, 146
5-3 Settlements Involving Educational Activities and Speaking and
Writing Arrangements, 149
6-1 Excerpts from Statements on Gifts by American Medical
Association and American College of Physicians, 177
6-2 Summary of Selected Recent Revisions in the PhRMA Code on
Interactions with Healthcare Professionals, 180
6-3 Examples of Prosecutions Involving Kickbacks to Physicians, 182
7-1 Cases and Controversies Involving Conflicts of Interest in Guideline
Development, 200
xix

xx BOXES, FIGURES, AND TABLES
7-2 Examples of Financial and Conflict of Interest Information
Excerpted from Summaries in the National Guideline
Clearinghouse, 202
7-3 Examples of Conflict of Interest Policy Descriptions Excerpted from
Summaries in the National Guideline Clearinghouse, 206
7-4 Policies of American College of Chest Physicians on Industry
Funding of Guideline Development, 208
7-5 Other Strategies for Limiting Bias in Clinical Practice Guideline
Development, 209
8-1 Cases and Controversies Involving Institutional Conflicts of
Interest, 217
9-1 Examples of Methods That Supporting Organizations Can Use to
Strengthen Conflict of Interest Policies, 236
E-1 Case Example of Successful Collaboration in Drug Discovery and
Development, 379
FIGURES
5-1 Sources of income reported by respondents (accredited providers of
continuing medical education) to ACCME annual survey, 1998 to
2007, 128
6-1 Percent change in average net physician income, adjusted for
inflation, 1995 to 2003, 168
E-1 Defining biomedical research from idea to market, 377
TABLES
S-1 Report Recommendations in Overview, 16
1-1 Timeline of Selected Events Relevant to the Evolution of Conflict of
Interest Principles, Policies, and Practices, 36
1-2 Selected Reports on Conflict of Interest Released Since 2000, 42
2-1 Criteria for Assessing the Severity of Conflicts of Interest, 53
2-2 Criteria for Evaluating Conflict of Interest Policies, 57

BOXES, FIGURES, AND TABLES xxi
3-1 Percentage of Medical Schools Requiring Further Disclosures for
Researchers with a Significant Financial Interest in Their
Research, 69
3-2 Percentage of Medical Schools Citing Different Management Policy
Options When Researchers Have a Significant Financial Interest in
Their Research, 84
3-3 Candidate List of Categories of Financial Relationships with
Industry to Be Disclosed, 93
4-1 Checklist for Reporting Clinical Trials from CONSORT 2001
Statement, 114
5-1 Third-Year Medical Studentsâ Interactions with Drug
Companies, 130
5-2 Share of Total Accredited Continuing Medical Education Income,
Instruction Hours, Participants, and Activities Accounted for by
Major Types of ACCME-Accredited Providers, 141
5-3 Income, Expenses, and Source of Support as Percentage of Income,
by Type of Accredited Provider of Continuing Medical Education,
2007, 144
7-1 Basic Elements of Process for Developing Evidence-Based Practice
Guidelines, 193
7-2 Number of Clinical Practice Guidelines in the National Guideline
Clearinghouse by Selected Types of Sponsors, as of March 16,
2009, 197
C-1
Summary of the Responses of Four Professions to Conflicts of
Interest, 356

Collaborations of physicians and researchers with industry can provide valuable benefits to society, particularly in the translation of basic scientific discoveries to new therapies and products. Recent reports and news stories have, however, documented disturbing examples of relationships and practices that put at risk the integrity of medical research, the objectivity of professional education, the quality of patient care, the soundness of clinical practice guidelines, and the public's trust in medicine.

Conflict of Interest in Medical Research, Education, and Practice provides a comprehensive look at conflict of interest in medicine. It offers principles to inform the design of policies to identify, limit, and manage conflicts of interest without damaging constructive collaboration with industry. It calls for both short-term actions and long-term commitments by institutions and individuals, including leaders of academic medical centers, professional societies, patient advocacy groups, government agencies, and drug, device, and pharmaceutical companies. Failure of the medical community to take convincing action on conflicts of interest invites additional legislative or regulatory measures that may be overly broad or unduly burdensome.

Conflict of Interest in Medical Research, Education, and Practice makes several recommendations for strengthening conflict of interest policies and curbing relationships that create risks with little benefit. The book will serve as an invaluable resource for individuals and organizations committed to high ethical standards in all realms of medicine.

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